Follistim AQ

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ganirelix
• follicle stimulating hormone 
• gonadorelin

 This is not a complete list of Follistim AQ drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Follistim AQ falls into category X. It has been shown that women taking Follistim AQ during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follitropin beta injection is used to treat infertility in both men and women. This medicine is a man-made hormone called follicle-stimulating hormone (FSH). FSH is produced in the body by the pituitary gland. FSH helps to develop eggs in the ovaries of women and sperm in the testes of men. Follitropin beta replaces natural FSH in the body.

Follitropin beta will help develop eggs in women who have not been able to become pregnant because of problems with ovulation. Some women will use this medicine while enrolled in a fertility program called Assisted Reproductive Technology (ART). ART uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin beta is used together with human chorionic gonadotropin (hCG) in these procedures.

Follistim® AQ Cartridge is also used in women with healthy ovaries who are undergoing reproductive procedures such as IVF or intracytoplasmic sperm injection (ICSI) cycle. This medicine is used together with human chorionic gonadotropin (hCG) in these procedures.

Follitropin beta is used together with human chorionic gonadotropin (hCG) to increase sperm production in men.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits while you are using this medicine, to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests will be needed to make sure that the medicine is working properly.

Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy if you get pregnant while undergoing IVF or ICSI procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain, tightness in the chest, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.

For women who are using this medicine:

• If your doctor has asked you to record your basal body temperature (BBT) each day, make sure that you understand how to do this. Carefully follow your doctor's instructions.
• This medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem that can be life-threatening. Stop using this medicine and call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble with breathing.
• This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using this medicine.

• Tell all of your health care providers that you take Follistim AQ. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of getting pregnant with more than one baby.
• This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.
• Your doctor may teach you how to give the shot.
• Follow how to use carefully.
• Wash your hands before and after use.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Upset stomach.
• Pimples (acne).
• Headache.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Follistim AQ, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Follistim AQ. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Follistim AQ.

Review Date: October 4, 2017

The following serious adverse reactions are discussed elsewhere in the labeling:

• Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2)]
• Atelectasis [see Warnings and Precautions (5.3)]
• Thromboembolism [see Warnings and Precautions (5.3)]
• Ovarian Torsion [see Warnings and Precautions (5.4)]
• Multi-fetal Gestation and Birth [see Warnings and Precautions (5.5)]
• Congenital Anomalies [see Warnings and Precautions (5.6)]
• Ectopic Pregnancy [see Warnings and Precautions (5.7)]
• Spontaneous Abortion [see Warnings and Precautions (5.8)]

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Ovulation Induction

In a single cycle, multi-center, assessor-blind, parallel group, comparative study, a total of 172 chronic anovulatory women who had failed to ovulate and/or conceive with clomiphene citrate therapy, were randomized and treated with Follistim (105) or a urofollitropin comparator. Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 2.

Adverse reactions reported commonly (greater than or equal to 2% of women treated with Follistim) in other ovulation induction clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage and injection site reaction.

In Vitro Fertilization/Intracytoplasmic Sperm Injection

In a single cycle, multi-center, double-blind, parallel group, comparative study, a total of 1509 women were randomized to receive controlled ovarian stimulation with either Follistim AQ Cartridge (751 women were treated with Follistim AQ Cartridge) or a comparator and pituitary suppression with a gonadotropin releasing hormone (GnRH) antagonist as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Table 3 lists adverse reactions with an incidence of greater than 2% in the group of women treated with Follistim AQ Cartridge.

Induction of Spermatogenesis

In an open-label, non-comparative clinical trial, 49 men with hypogonadotropic hypogonadism were enrolled to receive pretreatment with hCG, followed by combination therapy with hCG and Follistim for induction of spermatogenesis. Of the 49 men, 30 received weekly Follistim doses of 450 international units; 24 of these 30 men received a total of 48 weeks of treatment with Follistim. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with Follistim are listed in Table 4.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Follistim and/or Follistim AQ Cartridge. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders
Abdominal distension, abdominal pain, constipation, diarrhea

General disorders and administration site conditions
Injection site reaction

Reproductive system and breast disorders
Breast tenderness, metrorrhagia, ovarian enlargement, vaginal hemorrhage

Skin and subcutaneous tissue disorders
Rash

Vascular disorders
Thromboembolism [see Warnings and Precautions (5.3)]

Follistim AQ is injected subcutaneously (under the skin). You will be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used injections pens.

You must remain under the care of a doctor while using Follistim AQ.

The cartridge and injection pen are used only for an injection under the skin.

Follistim AQ comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor may occasionally change your dose to make sure you get the best results.

Prepare your Follistim AQ injection pen only when you are ready to give yourself an injection. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

If you use Follistim AQ to get pregnant, you may need to have sex daily for several days in a row. The timing of sex within your dosing schedule is important for this treatment to work.

To be sure this medication is helping your condition, your blood may need to be tested often. You may also need ultrasound exams. Visit your doctor regularly.

Storing unopened cartridges or injection pens: Keep in the carton and store in a refrigerator or at room temperature. Do not freeze. Protect from light and use within 3 months.

Storing after your first use: Keep the cartridge or injection pen at room temperature or in the refrigerator and use within 28 days. Protect from light.

Take the injection pen out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

Throw away any unused cartridges or pens after the expiration date on the label has passed.

Do not share Follistim AQ with another person, even if they have the same symptoms you have.